+ Manufacturing Vaccines in India – the Need of the Hour - CII Blog

We are adjusting to a new normal in an unprecedented time marked by COVID, wherein the key focus is on overcoming the slowdown induced by the pandemic and putting the economy once again on a growth trajectory.

It has been widely agreed that a turnaround in the economy largely depends upon aggressive vaccination of the entire population. This makes it imperative to ramp up the domestic manufacture of COVID vaccines. The Government envisages  the monthly production of Covishield to be increased to over 120 million doses and that of Covaxin to be increased to 58 million doses.

Vaccine production is a complex and time-consuming procedure, covering the entire spectrum from production of bulk material to filling the formulation in vials. Ramping up production could take two – three months, even if adequate funds are available.

The manufacturing of vaccines consists of two major parts – one, the active component or the bulk drug that is manufactured separately and two, the aseptic filling, which requires large facilities. Producing the bulk drug centrally and then sending to the manufacturing facilities for filling and finishing may enhance the speed of production. However, making bulk quantities is not a simple process and transfer of technology could take seven to nine months. Also, companies are facing limited resources for technology transfer.

Adequate raw materials, infrastructure, equipment, high level quality control and availability of skilled workforce are essential to reach optimum production of vaccines to meet the demand. The industry is keen to get the support of the Government in meeting these and also for all licenses wherever possible, to augment the production of vaccines domestically, which is absolutely essential to achieve vaccination at scale.

The companies need the help of the Government to ensure seamless supply of raw materials for vaccines from overseas. Advance purchase agreements, capacity subsidies and grants, and facilitating voluntary license agreements will help.

In the US and EU, the Governments have given advance purchase orders and payments to pharma companies. To ensure continued supply, the Government of India may work out possible solutions along with manufacturers.

On the issue of patent the Government may use negotiation skills. Waivers need to be backed by redesigning of supply chains, technology transfers, training of the workforce, and other necessary systems in place.

To ease approvals, providing a marketing approval by Drugs Controller General of India (DGCI) instead of manufacturers license and simplifying the test license regimen would help.

Subject Expert Committee (SEC) may have a permanent body of full-time experts in the respective fields which will result in faster approvals based on deeper scientific discussions.

It is necessary to address the vaccine hesitancy in people, especially in the rural areas. This may be done by means of aggressive campaigning and spreading awareness through effective mediums such as community radios and others.  

The supply chain may be strengthened and IT may be leveraged to identify any gaps that need to be covered.

An increased integration of technology in ensuring equitable distribution will help. Bridging the digital divide will ensure all communities are covered.

A strong Public Private Partnership should be forged in the vaccination mission. The best of both sectors – the scope and scale of the Government and the strengths of the Industry, including innovation, data and technology, knowledge of supply chain and human resources, among other strengths may be converged.

Vaccination is key for overcoming the COVID crisis. A synergy in efforts and focused approach is vital for restoring lives and livelihoods.